Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response

NCT ID: NCT06262932

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-12-31

Brief Summary

The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen

• Repeated dosing regimen
• Standard dosing regimen

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Repeated amiodarone bolus dosing regimen

An Initial 150 mg IV amiodarone bolus should be given over a 15-minute period. If the heart rate is still over 110 minutes after the initial treatment, provide an additional 150 mg IV amiodarone bolus over a 15-minute period. During the first 24 hours, this bolus may be administered up to three times in total. Within 24 hours of finishing the first bolus dosage, 900 mg of amiodarone will be administered intravenously.

Group Type: ACTIVE_COMPARATOR

Amiodarone

Intervention Type: DRUG

Assess the effectiveness of repeated bolus dosing strategies of amiodarone.

Standard dosing regimen

An Initial 150 mg IV amiodarone bolus should be given over a 15-minute period, then a 24-hour amiodarone loading infusion 900 mg over 24 hours

Group Type: ACTIVE_COMPARATOR

Amiodarone

Intervention Type: DRUG

Assess the effectiveness of repeated bolus dosing strategies of amiodarone.

Interventions

Amiodarone

Assess the effectiveness of repeated bolus dosing strategies of amiodarone.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age above 18 years old
• Atrial fibrillation with rapid ventricular response patient (ventricular rate > 110)

Exclusion Criteria

• Baseline EKG Corrected QT interval (QTc) < 500 msec
• History of pulmonary fibrosis
• History of Cirrhosis
• Cardiac Index <2.2 L/min/m2 or Cardiogenic shock
• Unstable arrhythmia
• Receive amiodarone within 3 months prior to present illness
• Pregnancy
• Amiodarone or Iodine allergy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Police General Hospital, Thailand

OTHER

Sponsor Role: lead

Responsible Party

Chawit Lopimpisuth

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Police general hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

RADS regimen

Identifier Type: -

Identifier Source: org_study_id